Ex Parte DeLuca et al

Patent Trial and Appeal Board

Jan 25, 2017

12958879 (P.T.A.B. Jan. 25, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
12/958,879 12/02/2010 Hector F. DeLuca 1256-01719 3961
81391 7590 01/25/2017
Andrus Intellectual Property Law, LLP
100 East Wisconsin Avenue
Suite 1100
Milwaukee, WI53202-4178
EXAMINER
KIM, JENNIFER M
ART UNIT PAPER NUMBER
1628
MAIL DATE DELIVERY MODE
01/25/2017 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HECTOR F. DELUCA, J. WESLEY PIKE, and
NIRUPAMAK. SHEVDE1
Appeal 2015-004839
Application 12/958,879
Technology Center 1600
Before JOHN G. NEW, RICHARD J. SMITH, and TAWEN CHANG,
Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of stimulating osteoblast cells to increase bone mineralization. We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 According to Appellants, the real party in interest is Wisconsin Alumni
Research Foundation. (Appeal Br. 1.)
Appeal 2015-004839
Application 12/958,879
STATEMENT OF THE CASE
Claims on Appeal
Claims 1—10, 20, and 25 are on appeal.2 (Claims Appendix, Appeal
Br. 11—17.) Claim 1 is illustrative and reads in pertinent part as follows:
1. A method of stimulating osteoblast cells to increase bone
mineralization in a mammal having a condition in which stimulating
osteoblast cells to increase bone mineralization has a therapeutic effect, the
method comprising administering to the mammal a therapeutically effective
amount of a compound having the formula:
(Id at 11-12.)
The compound of claim 1 is abbreviated as 2MD. (Appeal Br. 4.)
2 Claims 11—19, 21—24, and 26—28 are withdrawn from consideration. (Final
Act. dated May 15, 2014, at 1.)
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Application 12/958,879
Examiner’s Rejection
Claims 1—10, 20, and 25 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over DeLuca,3 Pietschmann,4 Hair,5 Bockman,6 and
Brenckmann.7 (Final Act. 2.)
Claims 1—10, 20, and 25 were not separately argued, and we therefore
limit our consideration to claim 1.
FINDINGS OF FACT
We adopt as our own the Examiner’s findings and analysis concerning
the scope and content of the prior art. The following findings are included
for emphasis and reference convenience.
FF 1. Appellants state that the 2-carbon-modified analogs of vitamin
D compounds are referred to as “2-carbon modified analogs” or “2-carbon
modified vitamin D compounds,” and that the Specification discloses a
specific 2-carbon-modified analog referred to as “2MD.” (Appeal Br. 4.)
FF 2. The Examiner finds that DeLuca teaches that compound 2MD
increases bone mass, and is useful for the treatment of diseases where bone
formation is desired, including various types of osteoporosis. (Final Act. 2;
Ans. 2-4, citing DeLuca Abstract, cols. 3 and 4, and claims 17—21.)
FF 3. Pietschmann teaches that “[ojsteocalcin ... is synthesized by
the osteoblasts. The serum levels of osteocalcin have been found to be a
3 DeLuca et al., US 5,843,928, issued Dec. 1, 1998 (“DeLuca”).
4 Pietschmann et al., Decreased Serum Osteocalcin Levels in Patients With
Postmenopausal Osteoporosis, 18 ActaMedica Sustriaca 5,114—16
(1991) (“Pietschmann”).
5 Hair et al., US 6,300,127 Bl, issued Oct. 9, 2001 (“Hair”).
6 Bockman et al., US 5,556,645, issued Sept. 17, 1996 (“Bockman”).
7 Brenckmann et al., Cochrane Database of Systematic Reviews 4,
CDE002010 (2001) (“Brenckmann”).
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Application 12/958,879
specific biochemical parameter of bone formation. . . . Serum levels of
osteocalcin were significantly lower in the patients with postmenopausal
osteoporosis.” (Pietschmann Abstract.)
FF 4. Hair teaches that “[ojsteocalcin has long been synonymous with
bone mineralization.” (Hair col. 12,11. 4—5.)
FF 5. Bockman teaches that “[b]one is formed by matrix-producing
cells known as osteoblasts.” (Bockman col. 3,11. 32—33.)
FF 6. Brenckmann teaches that “[ojsteoporosis is a disorder of bone
mineralization that can lead to reduced bone mineral density and an
increased risk for fractures.” (Brenckmann Background.)
DISCUSSION
We adopt and agree with the Examiner’s findings, analysis, and
conclusions as set forth in the Final Action (Final Act. 2—8) and Examiner’s
Answer (Ans. 2—5). We discern no error in the Examiner’s rejection of
claims 1—10, 20, and 25 as obvious.
Issue
Whether a preponderance of evidence of record supports the
Examiner’s conclusion of obviousness under 35 U.S.C. § 103(a).
Analysis
Appellants argue that “the claims recite a method of administering the
[2MD] compound to a new, nonobvious, specific class of patients.” (Appeal
Br. 6.) In support of that argument, Appellants explain that
A generic class of patients having a condition in which bone
formation is therapeutic such as osteoporosis may encompass (1)
a specific subclass of patients exhibiting impaired osteoblast
function, and/or (2) a specific subclass of patients exhibiting low
bone turnover. A generic teaching in the prior art related to
administering a vitamin D compound for treating a metabolic
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Application 12/958,879
bone disease such as osteoporosis is not a specific teaching to
administer the vitamin D compound for treating a condition that
is associated with impaired osteoblast function {i.e.,
administering the vitamin D compound to specific subclass (1)).
Nor would the claimed method be inherent in the prior art
method because although a generic class of patients having
osteoporosis may encompass (1) a specific subclass of patients
exhibiting impaired osteoblast function, the generic class of
patients having osteoporosis does not necessarily have to
encompass (1) a specific subclass of patients exhibiting impaired
osteoblast function.
{Id. at 7; see also Reply Br. 1—3.)
Appellants argue further that DeLuca “suggests that 2MD may be
administered to treat osteoporosis that derives from low bone turnover.”
(Appeal Br. 8.) Furthermore, according to Appellants, “[ujntil the present
inventors discovered that 2-carbon modified vitamin D compounds can
stimulate osteoblast cells to increase bone mineralization, it was not
recognized in the art that 2-carbon modified vitamin D compounds could be
administered to increase serum levels of osteocalcin.” {Id. at 8—9.)
We are not persuaded. A prior art reference may be read for all that it
teaches, including uses beyond its primary purpose. In re Mouttet, 686 F.3d
1322, 1331 (Fed. Cir. 2012). Accordingly, the teachings of DeLuca are not
limited to low bone turnover. {See FF 2.) Moreover, we agree with the
Examiner that it would have been obvious to administer the claimed
compound to the purported “class of patients,” recited in the preamble of
claim 1, based on the cited art. {See FF 2—6.) That is, it would have been
obvious to treat osteoporosis or other diseases where bone formation is
desired, as taught by DeLuca, by stimulating osteoblast cells to increase
bone mineralization, based on the teachings of Pietschmann, Hair, Bockman,
and Brenckmann. {Id.)
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Appellants also contend to have discovered a new use (“stimulating
osteoblast cells to increase bone mineralization”) for the compound of
DeLuca that is different from the use for treating low bone turnover.
(Appeal Br. 8—9.) However, numerous cases have found that the preamble
of a method claim, which stated the purpose or use for a method that was to
be performed, was not sufficient to distinguish prior art which carried out the
same steps of the method claim, albeit for a different purpose or use. See,
e.g., In re Cruciferous Sprout Litig., 301 F.3d 1343, 1351 (Fed. Cir. 2002);
Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1377—79 (Fed. Cir.
2005); In re Omeprazole Patent Litig., 483 F.3d 1364, 1373 (Fed. Cir.
2007). Here, the method step is the same as taught by DeLuca; namely,
administering an effective amount of the compound 2MD.
While the findings in the forgoing cases were in the context of
inherent anticipation, the cases nevertheless stand for the principle that a
claim preamble stating a purpose or use of a method does not alone
distinguish it from the prior art. An example in the obviousness context
includes In re Woodruff, 919 F.2d 1575 (Fed. Cir. 1990), where the claim at
issue included the preamble phrase “[a] process for inhibiting the growth of
fungi on fresh leafy and head vegetables.” (Id.) In affirming the rejection
for obviousness, the court stated that “what Woodruff terms a ‘new use’
(preventing fungal growth) is at least generically encompassed by the prior
art purpose of preventing the deterioration of leafy and head vegetables.”
(Id. at 1578.) Similarly, the preamble of claim 1 is at least generically
encompassed by the prior art purpose taught by DeLuca.
Appellants’ contention that they discovered a new use or property
(e.g., for 2MD) is likewise not sufficient to confer patentability. See
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Woodruff, 919 F.2d at 1578 (“It is a general rule that merely discovering and
claiming a new benefit of an old process cannot render the process again
patentable.”) (citing cases). Here, Appellants are at most claiming a new
benefit (“stimulating osteoblast cells to increase bone mineralization”) of the
process taught by DeLuca.
Conclusion of Law
A preponderance of evidence of record supports the Examiner’s
conclusion that claim 1 is obvious under 35 U.S.C. § 103(a). Claims 2—10,
20, and 25 were not argued separately and fall with claim 1.
SUMMARY
We affirm the rejection of all claims on appeal.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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